HealthyPhase 1NCT03316820
Bioavailability Study of K0706 in Healthy Subjects
A Phase 1 study testing K0706 in people with Healthy, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
Trial summary
This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- K0706
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2017to 21 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements
- Adult males or females aged between 18 and 55 years
- Medically healthy on the basis of medical history and physical examination
- Woman of childbearing potential must practice an acceptable method of birth control
Who cannot join
- History of any major surgical or medical conditions within 4 weeks prior to dosing
- History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing
- Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture
- Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Four Period, Four Sequence, Single Dose, Crossover Study to Evaluate Relative Bioavailability of K0706 24 mg Tablet Formulation Relative to 24 mg Capsule Formulation Under Fasted Conditions and to Evaluate the Food Effect for Tablet Formulation in Healthy Subjects
This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.
- Conditions
- Healthy
- Being tested
- K0706
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K0706Drug
Study treatment with water after an overnight fast
K0706Drug
Study treatment with water after food
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | K0706 tablet Receives: Drug: K0706 |
| Treatment B | Experimental | K0706 tablet Receives: Drug: K0706 |
| Treatment C | Experimental | K0706 tablet Receives: Drug: K0706 |
| Treatment D | Experimental | K0706 capsule Receives: Drug: K0706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed peak plasma concentration
Measured: 72 hours
Secondary outcomes (1)
Adverse event
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start28 Oct 2017
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316820
- Sponsor's protocol ID
- CLR_17_07
- Status last verified
- May 2019
- First submitted
- 17 Oct 2017
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Four Period, Four Sequence, Single Dose, Crossover Study to Evaluate Relative Bioavailability of K0706 24 mg Tablet Formulation Relative to 24 mg Capsule Formulation Under Fasted Conditions and to Evaluate the Food Effect for Tablet Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03316820
- Acronym / sponsor ID
- CLR_17_07
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: K0706K0706 tablet |
| Treatment B | Experimental | Drug: K0706K0706 tablet |
| Treatment C | Experimental | Drug: K0706K0706 tablet |
| Treatment D | Experimental | Drug: K0706K0706 capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements
- Adult males or females aged between 18 and 55 years
- Medically healthy on the basis of medical history and physical examination
- Woman of childbearing potential must practice an acceptable method of birth control
Key exclusion criteria (4 listed)
- History of any major surgical or medical conditions within 4 weeks prior to dosing
- History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing
- Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture
- Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K0706Study treatment with water after an overnight fast | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| K0706Study treatment with water after food | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
Observed peak plasma concentration
Time frame: 72 hours
1 secondary outcome
Adverse event
Time frame: 26 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing K0706 in people with Healthy, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed peak plasma concentration (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.